The Effect of Valproate on Benzodiazepine Withdrawal Severity - Full Text View

Sponsored by:	Helsinki University
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00570219

Purpose

The aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.

Condition	Intervention
Substance Withdrawal Syndrome	Drug: valproate

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Diazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients

Further study details as provided by Helsinki University:

Primary Outcome Measures:

benzodiazepine withdrawal severity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

benzodiazepine use [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
attrition from treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	February 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental Gradual benzodiazepine discontinuation and valproate treatment	Drug: valproate Valproate 20 mg/kg per day for 2 weeks, reduction during week 3. Conversion of benzodiazepines to an equivalent dose of diazepam (maximum 80 mg per day). Dosage reduced 10 mg daily until 40 mg per day. Reduction then continued 5 mg daily.
A: No Intervention Gradual benzodiazepine discontinuation

Detailed Description:

In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths.

Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of benzodiazepine dependence (DSM IV-R)
Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance

Exclusion Criteria:

Pregnancy
History of convulsions
Unstable somatic diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570219

Locations

Finland, Uusimaa
Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence
Helsinki, Uusimaa, Finland, 09

Sponsors and Collaborators

Helsinki University

Investigators

Principal Investigator:	Helena Vorma, MD, Ph.D	Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry
Study Director:	Katila Heikki, Md, Ph.D	Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry

More Information

Responsible Party:	Helsinki University Central Hospital, Department of Psychiatry ( Helena Vorma (principal investigator) )
Study ID Numbers:	PS05BENVAL, KLnro47/2005
Study First Received:	December 7, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00570219
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Substance Withdrawal Syndrome
Mental Disorders
Diazepam

Substance-Related Disorders
Disorders of Environmental Origin
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antimanic Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 13, 2009